Work Schedule

Third Shift (Nights)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Loud Noises (Equipment/Machinery)

Job Description

Job Summary:

Join Thermo Fisher Scientific Inc. as a QC Technician II and play an essential role in maintaining compliant manufacturing processes in Middletown. This is an outstanding opportunity to contribute to our world-class mission of enhancing global health and safety in a dynamic and regulated environment. Be part of an ambitious team dedicated to ensuring the highest quality standards.

Key Responsibilities:

Inspection:

Conduct inspections of finished products to ensure they meet predetermined quality standards and specifications.Perform functional testing and validation of products according to established protocols and procedures.Identify and document any defects or non-conformances.

Documentation and Reporting:

Maintain accurate and detailed records of inspections.Record and track non-conformances, corrective actions, and preventive measures.

Compliance and Standards:

Ensure all quality control activities align with ISO 13485 and other relevant regulatory standards.Assist in internal and external audits, providing necessary documentation and support.

Collaboration and Communication:

Work closely with production teams to address and resolve quality issues.Communicate effectively with other departments to ensure quality standards are understood and met.Provide guidance to production staff on quality control processes and standards as needed.

Continuous Improvement:

Participate in continuous improvement initiatives to enhance product quality and production efficiency.Find opportunities for process improvements and contribute to the development and implementation of quality control processes.

Safety and Environmental Compliance:

Follow all safety and environmental regulations and standards.Promote a safe working environment by following safety protocols and reporting any hazards.

Qualifications:

High school diploma or equivalent.Minimum of 2 years of experience in quality control, preferably in a manufacturing environment that adheres to ISO 13485 standards or other similar quality standard.Solid understanding of quality control principles, regulatory requirements, and ISO 13485 standards.Excellent attention to detail and problem-solving skills.Effective and collaborative communication abilities.Ability to work independently and as part of a team.

Physical Requirements:

Ability to walk and stand for prolonged periods at various times.Ability to lift and move objects up to 25 pounds.Ability to perform repetitive tasks.

Work Environment:

The job is performed on the production floor, which may involve exposure to noise, dust, and varying temperatures.Personal protective equipment (PPE) may be required.